CRM slump began in 2001, pacemaker trends show | MassDevice.com On Call

MASSDEVICE ON CALL — A study of pacemaker usage confirmed what most medical device makers already know all too well – the U.S. cardiac rhythm management market just isn’t what is used to be.

Stagnancy in the CRM arena has been an anchor weighing down many of the largest medical device makers, including rival medical device makers St. Jude Medical (NYSE:STJ) and Boston Scientific (NYSE:BSX), both of which have lamented the sluggish market and its impact on their quarterly earnings.

Pacemaker use increased 56% between 1993 and 2009, but most of that occurred in the 1990s and has leveled off since hitting a growth peak in 2001, according to a Reuters Health report.

Meanwhile, pacemaker patients have gotten older and sicker, the median age of a dual-chamber pacemaker recipient rising from 73 to 75 years old and exhibiting more co-morbidities than in 1993, according to the newswire.

Medtronic (NYSE:MDT) CEO Omar Ishrak has been more optimistic than his peers in predicting stabilization in U.S. CRM.

"The overall market is down in the U.S., but we do see that implant volume is growing," Ishrak said during a conference call with investors last month. "We were pleased to see relative sequential stability in the market."

Is the GOP losing favor on healthcare?
New polls find President Barack Obama’s healthcare reform act has gained significantly in popularity and that voters belief the incumbent president can do a better job managing the future of U.S. healthcare. Read more

Hospitals bite back against HHS warning on EMR fraud
The American Hospital Assn. charged back against warnings from Health & Human Services Secretary Kathleen Sebelius, arguing that the federal Medicare program needs to clean up its own coding before accusing care providers of deliberately misusing codes. Read more

The medical market for cosmetic devices is booming. However, quickly launching new products to meet demand is becoming more challenging because device manufactures face increased regulatory scrutiny. To help meet regulatory requirements, aesthetic and other medical-device OEMs are partnering with electronics manufacturing services (EMS) companies that also offer expertise with the FDA filings necessary to […]

Power Partners releases a new 310 Watt medical grade desktop power supply from their PEAMD Series of AC and DC adapters. The 310 Watt unit is packed for ideal performance inside a compact case measuring 7.8 x 4 x 2 in. with a weight of only 3 lbs. The PEAMD310 Series is approved to the latest […]

Saelig Company has introduced the ABI Electronics’ Multiple Instrument Station MIS4, an all-in-one testing tool that provides all commonly required test instruments in one compact programmable hardware module, mounted in a compact case or installed in a PC-drive bay. Controlled by ABI’s sophisticated SYSTEM 8 Ultimate PC software with a simple yet programmable operator interface, […]

AssurX, an enterprise quality management, risk and regulatory compliance solution provider, announces the release of the latest update to their AssurX document management software. The document management solution provides a cost-effective solution for small to medium sized companies faced with streamlined operations and is fully compliant for FDA regulated industries. Ideal solution for small to […]

Saelig Company announces the Amplicon Impact-R 1100F series, a fanless system powered by the Intel ATOM D2550 processor. Configured with a high performance 2.5 in. MLC Solid State Drive (SSD), the Impact-R 1100F series is a silent controller system. With options for multiple serial communication ports, the Impact-R 1100F can offer up seven DB9 connections […]

Gerresheimer AG, a partner to the global pharmacy and healthcare industry, will further extend its pharmaceutical packaging business with the acquisition of Centor. Gerresheimer has reached an agreement with Nemera Development S.A. to acquire 100% of the share capital of Centor US Holding. “Centor is the highly profitable market leader for plastic vials and closures in […]

Editor’s Note: This article is written by Ashley Boam and Mary Malarkey from the “FDA Voice” blog. Boam is an FDA’s acting Director of the Office of Policy for Pharmaceutical Quality, the Office of Pharmaceutical Quality and the Center for Drug Evaluation and Research. Malarkey is an FDA’s Director if the Office of Compliance and Biologics Quality […]